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Policies and Procedures

Research Finance Policies

Appendix A - Authorization and Acknowledgement of Arrangements for a Non-Division 08 Emp in Research Form
Employees Working in Beaumont Research Outside Their Normal Employment Duties
Establishing a Research Study Budget and Management of Research Funds
Research Time and Effort Reporting

Research Administration Policies

Biosafety Committee Operations
Clinical Research Quality and Process Improvement Program
Competitive Grant Proposal Development and Submission
Complaints, Allegations of Non-Compliance and Confirmed Non-Compliance in Clinical Research
Conflict of Interest for an Individual Involved in Research
Definition of Beaumont Health Research
Inquires and Investigations of Alleges Research Misconduct
Institutional engagement in research

Intellectual Property Policy
Intellectual Property Committee Operations
Processing Confidentiality Disclosure Agreements
Processing Data and Material Sharing Agreements
Protocol Review Committee Process
Research Administration Oversight
Responsibilities of the Principal Investigator
Scientific Review Committee Process
Transportation of Research Specimens

Institutional Review Board & Clinical Research Policies

Administrative Holds, Suspensions and Terminations
Amendment to the Protocol
Clinical Research Study Promotion
Clinical Studies Conducted in Full Compliance with ICH-GCP Guidelines
Community Based Participatory Research
Compensation and Incentives Offered to Research Participants
Continuing Review and Renewal of a Protocol
Coordinating Center and Lead Researcher Activities
Correction of Documentation
Criteria for Determining Frequency of Review by the HIC
Data Safety Monitoring
Defining Human Subjects Research
Determination of Significant Risk Device
Emergency use of a test article
Enrolling Non-English Speaking Study Participants
Enrollment of Visually Impaired Participants
Expanded Access and Use of Test Article for Compassionate Purposes
Expedited Review of Research
Guidelines for Blood Collection in Research
HIC Initial Review of Research Protocols
HIPAA and Research
Humanitarian Device Exemption
Inclusion of Women and Minorities in Clinical Research
Informed Consent and Authorization in Research
Institutional Authority

Investigational Device Studies
IRB Review of Research Involving Biospecimen Banking
Meetings of the Institutional Review Board
Organization of the Institutional Review Board
PI Notification of Review Outcome and Response Requirements
Planned Emergency Research
Protocol Deviations
Quality Assurance/Quality Improvement Projects
Recombinant DNA Research
Recruiting Human Subjects for Clinical Research
Reporting an Unanticipated Problem Involving Risk to Participants or Others
Research electronic data capture (redcap)
Research Exempt from Full HIC Review
Research Record Retention and Destruction
Review by an External Institutional Review Board
Single Time Emergency Use of a Test Article
Using Databases, Repositories, Registries in Research
Vulnerable Populations: Children as Research Subjects
Vulnerable Populations: Enrollment of Cognitively Impaired Participants
Vulnerable Populations: Enrollment of Employees, Students or Trainees
Vulnerable Populations: Inclusion of Pregnant Women, Fetuses and Neonates in Research
Vulnerable Populations: Participants Who Become Prisoners

Research Education Policies

Training and Education for Individuals Conducting Research

Clinical Research Standard Operating Procedures

Data Management
External Regulatory Body Inspections or Audits
Interactions with the Human Investigation Committee
Investigational and Study Agent Management
Investigational Device Accountability, Storage, Distribution and Return
Participant Recruitment and Screening
Pre-Study Site Selection Visit
Regulatory Files and Study Subject Records

Responsibilities of the Research Team
Site Initiation
Site-Sponsor/CRO Communications
Sponsor/CRO Monitoring Visits
Study Close-Out Visit
Subjects Removed, Withdrawn or Lost to Follow-Up
Training and education for individuals conducting research